Medtronic Closed-Loop Spinal Cord Stimulation System

  • End date
    Mar 31, 2025
  • participants needed
  • sponsor
Updated on 19 June 2022
spinal cord
limb pain
leg pain
intractable pain


The purpose of the study is to further understand the closed-loop feature in chronically implanted patients by characterizing the efficacy of the next generation, spinal cord stimulator.

Condition Low Back Pain, Leg Pain, Upper Limb Pain
Treatment Inceptiv
Clinical Study IdentifierNCT05177354
Last Modified on19 June 2022


Yes No Not Sure

Inclusion Criteria

years of age or older
Candidate is undergoing Medtronic SCS device trial for chronic, intractable pain of the trunk and/or limbs
If being treated for low-back and/or leg pain
the baseline overall^ Visual Analog Scale is ≥ 60 mm and
On stable (no change in dose, route, or frequency) prescribed pain medications being used for back and leg pain or upper limb pain, as determined by the investigator, for at least 28 days prior to device trial
baseline back and/or leg pain Visual Analog Scale is ≥60 mm. ^Average overall pain in the back and/or leg in the 72 hours prior to the baseline visit, measured using Visual Analog Scale
Willing and able to provide signed and dated informed consent
If being treated for upper limb pain - baseline Visual Analog Scale is ≥ 60 mm for
upper limb pain
Willing and able to comply with all study procedures and visits

Exclusion Criteria

Indicated for an SCS device to treat stable intractable Angina Pectoris or Peripheral Vascular Disease of Fontaine Stage III or higher
Previously trialed or implanted with spinal cord stimulator, peripheral or vagus nerve stimulator, deep brain stimulator or an implantable intrathecal drug delivery system
Currently participating, or plans to participate, in another investigational study unless written approval is provided by the Medtronic study team
Major psychiatric comorbidity or other progressive diseases that may confound study results, as determined by the Investigator
Serious drug-related behavioral issues (e.g. alcohol dependency, illegal substance abuse), as determined by the Investigator
Pregnant or planning on becoming pregnant (if female and sexually active, subject must be using a reliable form of birth control, be surgically sterile, or be at least 2 years post-menopausal)
Be involved in an injury claim or under current litigation
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How to participate?

Step 1 Connect with a study center
What happens next?
  • You can expect the study team to contact you via email or phone in the next few days.
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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